FDA Device recall Z-1660-2025
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Philips Brilliance CT Big Bore, Software Version 4.8.0.10430 by Philips North America, citing unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1660-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-01 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Reason
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Identifiers
| code_info | Model No. 728242, 728243, 728244; UDI: (01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)70…Model No. 728242, 728243, 728244; UDI: (01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)7056, (01)00884838098725(21)7060, (01)00884838098725(21)7062, (01)00884838098725(21)7064, (01)00884838098725(21)7072, (01)00884838098725(21)7087, (01)00884838059450(21)7096, (01)00884838059450(21)7123, (01)00884838059450(21)7124, (01)00884838098725(21)7128, (01)00884838098725(21)7135, (01)00884838098725(21)7154, (01)00884838098725(21)7163, (01)00884838098725(21)7179, (01)00884838098725(21)7191, (01)00884838098725(21)7220, (01)00884838098725(21)7221, (01)00884838098725(21)7229, (01)00884838059450(21)7240, (01)00884838098725(21)7245, (01)00884838098725(21)7246, (01)00884838098725(21)7247, (01)00884838098725(21)7254, (01)00884838098725(21)7256, (01)00884838098725(21)7282, (01)00884838098725(21)7283, (01)00884838098725(21)7292, (01)00884838098725(21)7297, (01)00884838098725(21)7304, (01)00884838098725(21)7306, (01)00884838098725(21)7309, (01)00884838098725(21)7311, (01)00884 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1660-2025%22
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